In a phase II study, treatment with 3 mg daily of CHS-131 reduced contrast-enhancing lesions by 52% over a 6-month period compared with placebo, according to David Weinstein, MD, PhD, chief scientific officer and chief medical officer of InteKrin Therapeutics of Redwood City, Calif., the developer of the agent.

In his poster presentation at the annual meeting of the Consortium of Multiple Sclerosis Centers, Weinstein reported that among the 69 evaluable patients with relapsing-remitting multiple sclerosis (RRMS) who were assigned to placebo there was a mean of 7.8 new lesions; among the 70 patients with RRMS assigned to the 1 mg dose of CHS-131, there was a mean of 7.6 new contrast-enhancing lesions; and among the 70 RRMS patients assigned to CHS-131 at the 3 mg dose there was a mean of 4.2 new lesions (P=0.003).

The study also illustrated that in cortical volume loss from baseline, the reduction after 6 months was 1.1% among patients on placebo and 0.7% among those on CHS-131, which amounted to a 34.2% reduction. The extent of atrophy loss between placebo and the 1-mg dose was not significantly different.

"We are continuing to do more studies with this agent," Weinstein told MedPage Today. "We would like to try a higher dose -- perhaps 5 mg or 6 mg. We believe this drug crosses the blood-brain barrier and may exert potent anti-inflammatory effects in the central nervous system."

"This is a promising drug," said Michael Racke, MD, of Ohio State University in Columbus, who was not involved with the study, but also has a relationship with the drug's developer. "One thing that is interesting about this trial is that it was performed in Russia, and all the patients in the study were vitamin D deficient. It turns out that vitamin D and PPAR interact, so I suspect that if this were done in the United States and you were supplementing vitamin D that the results would be even more efficacious."

Racke said that the PPAR-gamma agents used in diabetes such as rosiglitazone (Avandia) have been associated with cardiac problems, but the new agent has been designed to avoid those cardiac interactions. In fact, Weinstein reported that the researchers did not observe evidence of immunosuppression or common cardiovascular toxicities with CHS-131.

He said the drug may have a future as an add-on agent to other biologics or interferon-based therapies. However, if the vitamin D issues were corrected, the reduction in brain lesions might go as high as 80%, Racke added. "Where this will fit into practice if it does get approved will greatly depend on the company's strategy as to how they want to deploy it."

The study was conducted in Russia among multiple sclerosis patients who had received no prior treatment and had been diagnosed with the relapsing-remitting form of the disease within the last 3 years. All of the patients had an Expanded Disability Status Scale score of 6 or less at the time of screening and were required to have had at least one contrast-enhancing lesion during the previous 12 months but less than 10 at the time of screening.

The patients' mean age was 30 for those receiving the drug and 31 for those in the placebo group. A total of 60.5% of the patients given CHS-131 were women, compared with 74.3% of the placebo patients. All the patients in the study were Caucasian, and the mean score on the Expanded Disability Status Scale was 2.2.

Weinstein reported that 36% of patients on placebo reported adverse events compared with 26.3% of patients on the 1 mg dose and 32.6% of patients on the 3 mg dose of CHS-131. About 6.7% of patients on placebo were judged to have treatment-related adverse events compared with 3.9% of those on the 1 mg dose and 10.5% of those on the 3 mg dose. "However, no new safety signals were observed with CHS-131," Weinstein said.

The study was funded by InteKrin Therapeutics, now part of Coherus.

Weinstein reported being a consultant for Coherus in Redwood City, Calif.

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